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Tentative FDA approval for chemotherapy generic

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.

The originator product Aloxi/Onicit/Paloxi (palonosetron) is manufactured by Helsinn Birex Pharmaceuticals and was approved by FDA on 25 July 2003.  Palonosetron is a second generation 5-HT3 antagonist (anti-emetic) used in the prevention and treatment of chemotherapy-induced nausea and vomiting. 5-HT3 antagonists work by reducing the activity of the vagus nerve, which is a nerve that activates the vomiting centre in the medulla oblongata. It is used for the control of delayed chemotherapy-induced nausea and vomiting and there are tentative data to suggest that it may be better than granisetron, an older 5-HT3 antagonist.

Aloxi/Onicit/Paloxi had worldwide sales in 2013 of around US$625 million, according to IMS data. The product is the market leader for chemotherapy-induced nausea and vomiting and has had compound sales since launch of US$4.1 billion, making it a top seller in more than 50 countries worldwide.

The patent on Aloxi expired in the US on 13 October 2015. Both Sandoz, the generics division of Novartis, and Teva Pharmaceutical Industries received approval of their generic versions of injectable intravenous palonosetron on 13 October 2015.

Two applications for generics of palonosetron are also under review by the European Medicines Agency.

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